I recently came across an article in the NY Times entitled “Risks Seen in Cholesterol Drug Use in Healthy People.” To me this seems like an obvious statement. However, the FDA has recently approved the drug Crestor, a cholesterol lowering statin, for use in people with normal cholesterol levels.
AstraZeneca, the company who makes Crestor, has been hard at work trying to expand their market for this drug. It is the hallmark of the pharmaceutical industry. There are only so many sick people. What do you do when all of them are taking your drug? Expand to the healthy people.
This makes absolutely no sense at all. Putting healthy people on a drug for a supposed risk reduction should be criminal. There is no way that they risk does not outweigh the benefit. For example, recently published evidence indicates that statins could raise a person’s risk of developing Type 2 diabetes by 9 percent! By taking a statin you increase your risk of developing a disease that will create the problems you are trying to avoid in the first place.
The reason the FDA has approved this move you ask? Supposedly Crestor lowers inflammatory markers in the body. The inflammatory marker they are referring to is something called c-reactive protein or CRP. CRP has been linked to cardiovascular disease. The higher your CRP, the higher your risk for heart attack and stroke. It’s a pretty simple association. There is debate about whether it is a causal relationship, but from the research I have read, the lower your CRP the better off you are.
You might ask then what problem do I have with a drug that lowers an obvious risk factor for heart disease? My problem is that lowering CRP does not require a statin medication. I routinely measure CRP in my patients. Many people come back high in CRP and we put them on an anti-inflammatory diet, on anti-inflammatory supplements and recheck their blood work in 8-12 weeks. I have yet to fail to reduce anyone’s CRP. It isn’t rocket science. It is simple diet, exercise and supplementation. When people improve their overall health and lose weight, other health factors improve. The side effects from statins can be serious. That weighs heavy on the risk side of that all important risk:benefit ratio. The side effects to improving your diet, exercising and taking select anti-inflammatory supplements are virtually nil.
Under the new FDA approved guidelines an estimated 6.5 million people in this country who have no cholesterol problems and no sign of heart problems will be deemed candidates for statins. That is in addition to the 80 million who already meet the current cholesterol-based guidelines — about half of whom now take statins.
What a spectacular way to increase revenue. Just imagine you own and business and there is a segment of the population who has no reason to use your product. What if you could create a reason for them to use your product? It would be like owning a dress shop and convincing men that they need to wear dresses because it will increase virility.
Look at it this way; a 30 day supply costs between $60-$100 for Crestor. We’ll use an average of $80 to compute our numbers. (And I believe this to be a low estimate of cost as a number of sources put the cost of Crestor at $3.50 per pill for 30 tablets.) With this new approval there are 6.5 million potential new customers. At $80 per month that is potentially $520 million in extra sales per month or $6.24 billion per year!
Now, AstraZeneca knows that not all 6.5 million people who qualify for the drug will take it, but what if they just got an extra 100,000 people on it per year? That’s still $96 million in extra sales. No small amount.
The new Crestor guidelines continue a steady expansion of the number of people considered candidates for statins over the last decade. The recommendations and guidelines have been expanded by various advisory panels — many of whose members have also done paid consulting work for the drug industry.
Another of those panels is now preparing statin guidelines due next year, which are expected to further expand the number of candidates for the drugs. Just what we need. More people on statins. There are more effective ways to lower cholesterol. Drugs are not the answer.
The clinical trial on which the F.D.A. approved the new Crestor use was a global study of nearly 18,000 people. It looked only at patients who had low cholesterol and an elevated level of inflammation in the body as measured by the aforementioned CRP.
The study concluded that it reduced heart attack and stroke by similar numbers. The rate of heart attacks, for example, was 0.37 percent, or 68 patients out of 8,901 who took a sugar pill. Among the Crestor patients it was 0.17 percent, or 31 patients. That 55 percent relative difference between the two groups translates to only 0.2 percentage points in absolute terms — or 2 people out of 1,000.
Stated differently, 500 people would need to take Crestor for a year to prevent 1 heart attack, most of which are survivable.
What if those people, instead of being given a drug, were taught how to eat properly, exercised and took some proven anti-inflammatory supplements? I believe we would see a much larger reduction in heart attack and stroke not only because their health would improve, but because of the other benefits of eating right and exercising. Unfortunately, I do not have a randomized, placebo controlled study to point to because these things are not studied. Funds are not allocated to unpatentable products and exercise regimes.
At a time when we are trying to reduce health costs in this country, spending $638,000 to reduce the risk of one heart attack or stroke doesn’t make sense. Not when there are other ways that are less expensive and likely more effective. The pharmaceutical industry will never stop trying to expand its market. We have to be educated to know that there are safer, more natural ways to improve health.